Excellent Positive Results from Phase 3 Randomised Clinical Trial of FortacinTM/SenstendTM in China
Good Tolerance and No Systemic Side Effects for Treatment of Pre-mature Ejaculation and Well Tolerated by Chinese Patients
(17 April 2023, Hong Kong) – Endurance RP Limited (“Endurance” or the “Company” and collectively with its subsidiaries, the “Group”; stock code: 0575.HK) is pleased to announce its commercial strategic partner Wanbang Biopharmaceutical Co., Ltd. (“Wanbang Biopharmaceutical”) has successfully completed the Phase 3 double-blind placebo-controlled study of Senstendä in China for the treatment of premature ejaculation (“PE”).
The study recorded excellent positive results which met all four co-primary endpoints of Intra-vaginal Ejaculation Latency Time (“IELT”), Index of Premature Ejaculation (“IPE”) Ejaculatory Control and IPE Sexual Satisfaction domains and IPE Distress. Compared to both baseline and placebo, Senstendä produced clinically and statistically significant increases in IELT, ejaculatory control and satisfaction and reduction in distress. Consistent with our previous studies undertaken in Europe and the United States (“US”), SenstendTM was well-tolerated by both Chinese patients and partners and no new side effects were reported.
In this study, there was a study population of 295 male patients aged 20 years or above who were diagnosed with PE, with 197 patients in the SenstendTM group and 98 in the placebo group. Patients were treated for three months at multiple sites in China.
Jamie Gibson, CEO of the Group, said, “We are delighted with the highly significant and positive results from the Phase 3 clinical study in China, which reinforces the results from the European and US Phase 3 clinical studies. This represents an important milestone in the regulatory submission process in China. We now look forward to our commercial partner in China submitting the New Drug Application (“NDA”) to National Medical Products Administration (“NMPA”) by the end of Q3 2023 with approval expected 12 months later.”
Jamie Gibson further added, “SenstendTM has the potential to help about 9 million patients in China during its first year of launch, growing to over 170 million by the tenth year. Our strong partner Wanbang Biopharmaceutical, who benefits from being part of the Fosun network. This company has the marketing expertise established e-commerce platforms and an unrivalled nationwide logic and distribution through Sinopharm, China’s number one pharmaceutical and healthcare distributor, through its network of hospitals, clinics and pharmacies to ensure the commercial success of SenstendTM in China.”
Commercial Milestone Payments from Wanbang Biopharmaceutical
All costs of the clinical trials, including any other associated regulatory and submission costs for Senstend™ are covered by Wanbang Biopharmaceutical. The group will receive US$5 million (or approximately HK$39 million) (before deduction of PRC withholding tax) assuming NMPA approval for importing Senstend™ is granted and US$2 million (or approximately HK$15.60 million) (before deduction of PRC withholding tax) upon first commercial sale of Senstend™ in China, from Wanbang Biopharmaceutical.
Additionally, as disclosed on 3 December 2018, there are other significant payments payable to the Group from Wanbang Biopharmaceutical. A payment, which could total up to US$25 million (or approximately HK$195 million) will be made upon the achievement of certain annual net sales milestones by Wanbang Biopharmaceutical and the Group will receive 25 percent of net receipts and tiered percentage royalties on net sales, ranging from the low to high teens, except for circumstances in which a generic product has successfully entered and impacted the market in China, where lower payment structures will apply.
European Market Update
The Company reports positive results in certain countries in the European Union, where FortacinTM has returned to the market. Patients have responded positively, with the first batch of units in Germany experiencing strong demand. The manufacturer has released 30,000 units in February 2023, and the next 30,000 units are scheduled for delivery in July 2023.
SenstendTM (the brand name for FortacinTM in China) is a metered dose aerosol from a proprietary formulation of two marketed drugs, lidocaine and prilocaine, developed for treating premature ejaculation. The disorder affects approximately 20% to 30% of men in China, which translates to a significant initial target male population of approximately 55 million men aged between 20-59 years old, based on World Bank 2022 estimates rising to over 170 million men. In December 2018, Plethora signed an exclusive license agreement with Wanbang Biopharmaceutical Co., Ltd, a wholly controlled company of Shanghai Fosun Pharma, to market SenstendTM for premature ejaculation in China.
About Endurance RP Limited (Stock code: 0575.HK)
Endurance is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders since its initial public offering in May 1997.